Kornimate/medical-research-clean huggingface dataset:
conventional curettage adenoidectomy vs curettage adenoidectomy with transoral endoscopic residue ablation in children

Conditions: Adenoid Hypertrophy

Summary: this prospective study is designed to compare short and long term results of conventional cold curettage adenoidectomy in children performed without doing any endoscopic or mirror examination before ending the operation versus when combined with transoral endoscopic residue ablation using a wand.

residual or recurrent adenoid tissue that causes persistence or recurrence of symptoms is observed frequently after conventional cold curettage adenoidectomy. new techniques to better visualize or excise the tissue in order to prevent this situation are being developed. this study aims to compare transoral endoscopic controlled adenoidectomy with conventional blind curettage adenoidectomy in terms of recurrent adenoid hypertrophy. although there are other studies comparing the results of the two techniques in terms of early residual adenoid tissue and bleeding, no studies comparing the long term results were found in literature. this prospective study is planned to focus on both early examination of residual tissue and long term recurrence.

Eligibility criteria:
inclusion criteria: * patients within 3-12 years old * patients undergoing tonsillectomy and adenoidectomy for obstructive sleep disorder * patients undergoing adenoidectomy and ventilation tube insertion for chronic otitis media with effusion (ome) * patients undergoing adenoidectomy alone for obstructive sleep disorder * patients undergoing adenoidectomy alone for chronic ome * patients undergoing adenoidectomy alone for chronic sinusitis exclusion criteria: * patients not between 3-12 years old * patients with craniofacial anomalies * revision adenoidectomy * proven significant comorbidities * systemic diseases * bleeding diathesis

Keywords: adenoidectomy adenoids curettage
sample collection study to assess prevalence of gene mutations: establishing population norms

Conditions: Photoaging

Summary: this is a multi-center, sample collection study to quantitatively assess the presence of gene mutations in subject's skin collected non-invasively. subjects who consult with a dermatologist or other clinicians will be approached for participation in the study. once irb approved informed consent is obtain, subject demographic information, history of sun exposure and samples will be collected.

this is a multi-center, sample collection study to quantitatively assess the presence of gene mutations in subject's skin collected non-invasively. subjects who consult with a dermatologist or other clinicians will be approached for participation in the study. once confirmation of participation is confirmed subjects will undergo the informed consent process. once consented the subject will have their medical history reviewed, concomitant medications and demographic information recorded, complete a sun-exposure questionnaire, have photoaging characteristics (such as melasma, wrinkles, ak lesion(s)) recorded, record their assessment of photoaging, have skin samples collected non-invasively and complete the local skin reaction and local tolerability assessments. a select number of subjects will also have a facial photograph taken. if the location to be sampled contains a lesion, then the collection should occur as close as possible to the target area. the site staff and/or subject will be responsible for collecting the skin samples.

Eligibility criteria:
inclusion criteria: 1. males and females at least 21 years of age presenting to the clinic for medical consultation; 2. in good health, determined by no clinically significant findings from medical history, 3. willing to complete all study procedures required by the protocol; and 4. willing to provide informed consent to participate in this trial. exclusion criteria: 1. have any skin disorder including acne, rosacea, psoriasis, atopic dermatitis and active skin cancer(s) that appear in the facial area where sample collection will be taken and could confound the results of the trial; 2. has a suspicious lesion (i.e., actinic keratosis lesion) in an area that is expected to be sampled and requires further medical follow-up, 3. pregnant or breast feeding, 4. hospitalization within 4 weeks before enrollment, 5. previously provided samples for this study, 6. receipt of any investigational drug therapy within four weeks of study enrollment, or concurrent participation in another interventional clinical study, 7. documented substance abuse, any other significant medical condition that would indicate an unreasonable risk to the potential study participate or potential interference with the procedures, or would negatively affect the study subject's reliability and compliance with the study schedule of events, and 8. chemical peel or treatment with a laser in the facial area within 3 months prior to enrollment.
comparing laboratory blood glucose results with hemocue glucose 201 rt

Conditions: Cystic Fibrosis

Summary: there are very few studies comparing the accuracy, sensitivity and specificity of hemocue glucose 201 rt system with the laboratory gold standard. the incidence of cystic fibrosis related diabetes (cfrd) has risen significantly as patients' survival improves. around 30% of all cystic fibrosis (cf) adult patients have cfrd. early diagnosis of cfrd is important to slow the deterioration of lung function and nutritional status, both of which increase mortality. the oral glucose tolerance test (ogtt) is the accepted method for detecting cfrd and the cystic fibrosis trust guidelines recommend that patients with cf over the age of twelve years should be screened annually. the world health organisation has pointed out that due to the absence of a more specific biological marker to define diabetes, plasma glucose estimation remains the basis of diagnostic criteria. who recommends that venous plasma glucose should be the standard method for measuring and reporting glucose concentration in blood. however, it has also recognised that there is a widespread use of capillary sampling. although fasting values for venous and capillary plasma glucose are the same, in the nonfasting state capillary samples will give higher results than venous samples, and glucose values require conversion which can be problematic. hemocue glucose 201 rt (hgs 201 rt) analyzer with plasma conversion provides laboratory quality test results at the point of care for the diagnosis, screening and monitoring of diabetes mellitus. the analyzer is easy to use and the system can be operated by nonlaboratory personnel, also the results can be presented immediately, leading to significant time and resource saving. the patient also benefits from having the result immediately instead of waiting for several hours. with immediate result, the doctor and health care professionals can provide education, support and reassurance, and implement care plans, if appropriate, at the earliest opportunity. the aim of the study is to compare the clinical accuracy of hemocue glucose 201 rt with the laboratory standard method in the analysis of blood glucose concentration during oral glucose tolerance test.

all cf patients attending annual review who require an ogtt will have a venous and a capillary blood sample taken simultaneously before (fasting = 0 min) and 2 hours (post glucose load = 120 min) after the administration of 75 grams glucose solution orally. the capillary sample will be analysed immediately using hgs 201 rt. the venous sample will be collected in a fluoride oxalate tube (who guideline) and sent to the trust's laboratory for analysis as per usual practice.

Eligibility criteria:
inclusion criteria: the first 70 consecutive suitable consenting adult cf patients, who are 16 years of age and over, attending annual review at the royal brompton hospital from june 2013 to march 2014, are eligible for the study exclusion criteria: patients with an existing diagnosis of cfrd are exclude.

Keywords: cystic fibrosis cystic fibrosis related diabetes oral glucose tolerance test
increase protein intake of older meal service clients with readymade protein-rich meals and foods

Conditions: Malnutrition; Protein; Protein Malnutrition

Summary: rationale: undernutrition risk among community-dwelling older adults in developed countries is shown to be around 24%. increasing protein intake is a strategy that is feasible as well as efficacious to reduce undernutrition in community-dwelling older adults. a promising strategy to increase protein intake among older adults, is to offer dietary solutions with normal foods that fit their current daily eating patterns. for this reason, home-delivered protein-rich readymade meals and protein-rich dairy products will be studied in this research. objective: the primary objective is to study the effectiveness of commercially available protein-rich readymade meals and protein-rich dairy products in increasing protein intake of older adults who use a meal-delivery service to a level of 1.2 g/kg bodyweight/d. secondary objectives include: studying effects of these meals and dairy products on total daily energy intake. further, studying the acceptance of and compliance to the meals and dairy products. study design: the study will be performed as a single-blind randomized, controlled, four-week trial in a real-life setting: in community-dwelling older adults' own homes. study population: the target group of this study are community-dwelling older adults who use a meal-delivery service. intervention: both groups will receive readymade meals for each day during 4 weeks. they will also receive dairy products to freely consume during the intervention period. the intervention groups receives protein-rich meals and protein-rich dairy products, the control receives standard meals and food products. main study parameters/endpoints: difference in daily protein intake between intervention and control group. secondary parameters: energy intake and acceptance (liking).


Eligibility criteria:
inclusion criteria: * aged 65 years or over * living at home * be a client of maaltijdservice.nl * being able to eat by themselves * have a microwave to heat meals * live in nijmegen or den bosch area * being able to understand, read and speak dutch * having signed informed consent. exclusion criteria: * legally incapacitated * mini mental state examination (mmse) score \< 24 * following a diet with protein restriction or a vegetarian diet * allergies or intolerances prohibiting the use of dairy products * only using texture modified foods (liquid diet) * diagnosed by doctor with renal insufficiency * suffering from a terminal illness

Keywords: protein intake older adults protein-rich acceptance liking readymade meals
restoration® anatomic dual mobility (adm) x3® acetabular system study

Conditions: Arthroplasty, Replacement, Hip

Summary: the purpose of this study is to evaluate the success rate of cementless primary hip replacement with the restoration® adm x3® acetabular system as compared to other primary hip systems in the literature, through absence of femoral head dislocation at 10 years postoperative.

this study is a prospective, open-label, post-market, non-randomized, multi-center, clinical evaluation of the restoration® adm x3® acetabular system for primary total hip arthroplasty (tha) with a cementless application in a consecutive series of patients who meet the eligibility criteria. the total enrollment goal for the study is 350 cases, all of which will receive the restoration® adm x3® acetabular system. a minimum of 100 cases (within the study population) will receive the accolade® ii hip stem. the remaining cases will receive any other compatible stryker femoral component. data in the literature from other primary hip systems and similar dual mobility cups will be used as historical references.

Eligibility criteria:
inclusion criteria: * patient has signed an irb/ec approved, study specific informed patient consent form. * patient is a male or non-pregnant female, skeletally mature and age 18-75 years at time of study device implantation. * patient has a diagnosis of non-inflammatory degenerative joint disease (nidjd). * patient is a candidate for a primary cementless acetabular replacement. * patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation. exclusion criteria: * patient has a body mass index (bmi) ≥ 40. * patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation. * patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device. * patient is diagnosed with a systemic disease (e.g. lupus erythematosus) or a metabolic disorder (e.g. paget's disease) leading to progressive bone deterioration. * patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days). * patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint. * patient has a known sensitivity to device materials. * patient is a prisoner.

Keywords: noninflammatory joint disease of the hip.
clinical study of genakumab for injection in chinese healthy volunteers

Conditions: Juvenile Idiopathic Arthritis

Summary: to evaluate the safety and tolerability of single subcutaneous injection of genakumab for injection in chinese healthy adult volunteers

there are 5 dose groups with 8 participants in each group, including 6 participants in the experimental group and 2 participants in the placebo control group. since the strength of experimental drug is 150mg/1ml/ bottle, participants with a single dose of more than 150mg need to be given subcutaneously at different sites in two or more times

Eligibility criteria:
inclusion criteria: * 18 years ≤ age ≤50 years, and in good health; * 40kg ≤ weight ≤100kg , and body mass index is within the range of 18 - 28 kg/m\^2 (including 18 kg/m\^2 and 28 kg/m\^2); * no parental scheme from the screening period to 6 months after the study period. exclusion criteria: * participants have abnormal physical and auxiliary examination results with clinical significance; * history of cardiovascular, liver, kidney, digestive, blood, nervous system and allergic diseases, mental and metabolic disorders, acute or chronic bronchospastic disease; * smoking more than 5 cigarettes per day; * participants who use any prescription drugs within 4 weeks prior dosing, or over-the-counter medication within 2 weeks prior to dosing. participants who receive treatment of any biologics within three months prior to dosing. participants who receive (attenuated) live vaccines within six months prior to dosing; * participation in any clinical investigation within 3 months prior to dosing; * donation or loss of 400 ml or more of blood within 3 months prior to dosing; donation or loss of 200 ml or more of blood within 4 weeks prior to dosing; or donation of component blood within 2 weeks prior to dosing; * tuberculosis symptoms, contact with patients with suspected tuberculosis symptoms * positive results in hepatitis b surface antigen (hbsag), hepatitis c antibody, syphilis antibody or hiv antibody; * clinically significant acute infection within 2 weeks prior to dosing; * current or previous drug or alcohol abuse; * other conditions in which the investigator preclude enrollment into the study.
prospective evaluation of the role of mri in ovarian masses during pregnancy

Conditions: Ovarian Cancer

Summary: ovarian cancer represents 7% of all cancers in pregnant women. characterizing an ovarian mass during pregnancy is essential to avoid unnecessary treatment and if treatment is required, to plan it accordingly. ultrasound is the first line modality in these patients and various tools such as iota and adnex have been validated in non-pregnant patients to accurately categorize ovarian masses according to their malignant potential. a prospective multicentre study, in which fondazione policlinico gemelli is involved, is currently ongoing aiming to validate these tools in pregnant patients (p-iota). given the high contrast resolution and the absence of ionizing radiation, magnetic resonance imaging is the preferred second-line modality. it increases the positive predictive value (ppv) of us from 7-50% to 70%, demonstrating a negative predictive value (nv) of 98%. in non-pregnant women, the ovarian-adnexal reporting and data system-mri (orads-mri) risk stratification system and the non-contrast mri score (ncms) are commonly employed to assess the risk of malignancy in adnexal lesions with accuracies of 92% and 94%, respectively. recently, both scoring systems have proven effective in retrospectively stratifying benign and malignant adnexal masses in pregnant women.


Eligibility criteria:
inclusion criteria: * pregnant patients \&gt; 18 years old * ability to understand and sign informed consent * patient with adnexal mass detected during pregnancy with either multilocular morphology or solid component at ultrasound examination * availability of mr imaging (1.5t and 3.0t mr scanner) * availability of histopathological reports obtained during pregnancy or within 3 months from delivery or at least one us follow-up examination 6-12 months after mri examination exclusion criteria: * patients lacking or with low quality mri
the effect of hallux valgus angle on dynamic knee movement pattern

Conditions: Hallux Valgus

Summary: abstract background/aim: little is known about the relationship between hallux valgus and the alignment of proximal joints. dynamic knee valgus is a movement pattern characterized by excessive knee abduction along with femoral adduction, internal rotation, and relative external tibial rotation. it is more prevalent in females and exacerbates during landing in jumping, predisposing athletes to injuries. the aim of this study is to investigate the effect of hallux valgus deformity on dynamic knee movement pattern and lower extremity injuries in athletes. materials and methods: this is a cross-sectional observational study. the study included 92 athletes with at least 3 years of experience in their respective sports.

athletes without acute injuries that could affect performance tests were included. demographic data were collected, and the hallux valgus angle was measured using a goniometer. a standard warm-up protocol was then administered. a drop jump test from a 30cm platform was conducted, and images captured during the test were analyzed in 2d using kistler+noraxon measurement device cameras.

Eligibility criteria:
inclusion criteria: * at least 3 years of experience in their respective sports. exclusion criteria: * athletes with acute injuries

Keywords: hallux valgus injury judo knee weightlifting
ifaam: the impact of proton-pump inhibitors (antacids) on threshold dose distributions

Conditions: Food Allergy

Summary: in patients with a walnut allergy double blind placebo controlled food challenge with walnut will be combined with the intake of proton pump inhibitor (ppi) or with placebo to assess the impact of ppi on threshold level and on clinical manifestation.

1. detailed case history, blood sampling and prick testing with different foods will performed. 2. double blind food provocation with with three meals containing either placebo or walnut in walnut allergic patients will be performed. 3. the provocation will be combined with the intake of drug (omeprazole) or placebo (mannitol) blinded in capsules.

Eligibility criteria:
inclusion criteria: * signed informed consent, history of walnut allergy,minimum age 18 years exclusion criteria: * • known hypersensitivity or allergy to omeprazole, other proton pump inhibitors, mannitol, ingredients of placebo meal * drugs not allowed during the study due to proved interaction with omeprazole: digoxin, clopidogrel, methotrexate, antiretroviral drugs, diazepam, cilostazol, phenytoin, warfarin (r-warfarin) and other vitamin k antagonists, phenytoin, tacrolimus, clarithromycin, voriconazole, rifampicin and hypericum * drugs not allowed due to interference with the food challenge (or shortest interval between last treatment and food challenge) * corticosteroids systemically (2 weeks) * antihistamines (3 days) except hydroxyzine (10 days) * ketotifen (2 weeks) * betablocker (1 day) * angiotensin converting enzyme (ace) inhibitors (2 days) * omalizumab (2 months) * women who are pregnant or breast feeding * intention to become pregnant during the course of the study * lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices * please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential. * uncontrolled asthma, forced expiratory volume \<70% predicted value * acute allergic disease * chronic urticaria * mastocytosis * other clinically significant concomitant disease states (major organic or infectious diseases, e.g., renal failure, hepatic dysfunction, cardiovascular disease, acute febrile infection), * known or suspected non-compliance, drug or alcohol abuse, * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * participation in another study with investigational drug within the 30 days preceding and during the present study